FDA: The Voice of the Patient

On April 25, 2013, FDA held a public meeting to hear perspectives from patients with ME/CFS about their disease, its impact on their daily life, and currently available therapies. The Solve ME/CFS Initiative was there and on May 17th we reported on the meeting in this summary post.

As a part of our participation in that meeting, we conducted a survey to solicit patient input to present to FDA. On May 29th, we reported on our survey – findings that were presented to FDA at the meeting and again, in full, prior to the final deadline for public comment on August 2nd.

Recently, FDA released their report on this meeting. The report acknowledges that the input FDA received through the meeting and the public docket underscores the chronic and serious nature of ME/CFS. The full range of cognitive and physical symptoms discussed by participants are described on pages 6-10, while participants’ discussion on the range of treatments, their effectiveness and their downsides is described in more detail on pages 11-13. The report then summarizes all of the public comments, including those submitted by the Association. (Made possible due to the tremendous response we received to our online survey.)

The report concludes by stating,

“FDA recognizes that patients have a very unique ability to contribute to our understanding of this broader context of the disease, which is important to our role, and that of others, in the drug development process. We share the patient community”s commitment to facilitate the development of safe and effective drug therapies for this disease.“

FDA is continuing the conversation and your voice is important in that dialogue. On October 16 from 1:30 PM – 3:00 PM EST, FDA will hold a teleconference that is open to the public. FDA will provide introductory and background remarks then the teleconference will be open for public comment on the following three topics:

In order to move forward more swiftly and to achieve better understanding, diagnosis and treatments, we must broaden support for ME/CFS research at all levels. The attention received by FDA through this effort is an opportunity to continue the building of a strong federal base of support. This dialogue helps open the door to validation, funding and future research centered on the patient’s experience with ME/CFS. To the degree that you are able, please consider participating.